Daily Rules, Proposed Rules, and Notices of the Federal Government
This notice of final rulemaking is organized as follows:
Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program within the Department of Health and Human Services (HHS). The PHS Act requires the WTC Program Administrator (Administrator) to conduct rulemaking to propose the addition of a health condition to the List of WTC-Related Health Conditions (List) codified in 42 CFR 88.1 regardless of whether the Administrator proposes to add a health condition based on the findings from periodic reviews of cancer,
This rule modifies the List of WTC-Related Health Conditions in 42 CFR 88.1 to add the following conditions (types of cancer identified by ICD-10 code are specified in the discussion below):
The Administrator developed a hierarchy of methods (detailed in Section IV of this preamble) for determining which cancers to propose for inclusion on the List of WTC-Related Health Conditions.
Annual costs, benefits, and transfers of this rule are listed in the table below. This analysis estimates the impact on WTC Health Program costs using the number of persons currently enrolled in the Program as responders and survivors and assumes that the rate of cancer in the population will be equal to the U.S. population average rate. An alternative analysis considers the impact on costs if the Program enrolls additional persons up to the Program's statutory limits, and that the expanded population experiences a 21 percent higher rate of cancer than the U.S. population average. The basis for these assumptions is explained in detail in the preamble of this rulemaking (see Section VII.A., below).
Although we cannot quantify the benefits associated with the WTC Health Program, enrollees with cancer are expected to experience a higher quality of care than they would in the absence of the Program. Mortality and morbidity improvements for cancer patients expected to enroll in the WTC Health Program are anticipated because barriers may exist to access and delivery of quality health care services for cancer patients in the absence of the services provided by the WTC Health Program. HHS anticipates benefits to cancer patients treated through the WTC Health Program, who may otherwise not have access to health care services, to accrue in 2013. Starting in 2014, continued implementation of the Affordable Care Act will result in increased access to health insurance and improved health care services for the general responder and survivor population that currently is uninsured.
On June 13, 2012 HHS published a notice of proposed rulemaking (77 FR 35574) proposing to add certain cancers to the List of WTC-Related Health Conditions. HHS invited interested persons or organizations to submit written views, opinions, recommendations, and data on any topic related to the proposed rule. The Administrator specifically sought comments on the methodology proposed to evaluate evidence for the addition of types of cancer to the List of WTC-Related Health Conditions; the proposed cost estimates; information or published studies about the type of welding and/or metal cutting that occurred at any of the disaster sites and information about exposure to ultraviolet light; and information or published studies about the scheduling of work hours or shiftwork occurring at any of the disaster sites.
HHS received 27 substantive submissions to the docket for this rulemaking. Commenters included labor unions that represent WTC responders, including police department members and others who conducted rescue, recovery, and clean-up; private citizens, including WTC responders; the spouse of a responder; survivors; relatives of victims and survivors; physicians who have treated WTC responders; health care professionals with no stated experience treating 9/11-exposed patients; health and research organizations; the WTC Health Program Survivors Steering Committee; a chemical supplier; and an elected official. Additionally, one private citizen submitted a comment that was outside the scope of this rulemaking. The substantive comments are described below, followed by the Administrator's response to each (see Section V., below).
Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347), amended the PHS Act to add Title XXXIII
All references to the Administrator in this notice mean the NIOSH Director or his or her designee. Section 3312(a)(6) of the PHS Act requires the Administrator to conduct rulemaking to propose the addition of a health condition to the List of WTC-Related Health Conditions codified in 42 CFR 88.1.
The PHS Act requires the Administrator to conduct rulemaking to propose the addition of a health condition to the List of WTC-Related Health Conditions codified in 42 CFR 88.1 regardless of whether the Administrator proposes to add a health condition based on the findings from periodic reviews of cancer,
On October 5, 2011, the Administrator formally exercised his option to request a recommendation from the STAC regarding the petition (PHS Act, sec. 3312(a)(6)(B)(i); 42 CFR 88.17(a)(2)(i)). The Administrator requested that the STAC “review the available information on cancer outcomes associated with the exposures resulting from the September 11, 2001, terrorist attacks, and provide advice on whether to add cancer, or a certain type of cancer, to the List specified in the Zadroga Act.”
As reviewed in detail in the June 13, 2012 notice of proposed rulemaking, the
In September 2011, an epidemiologic study by Rachel Zeig-Owens and colleagues (hereafter, “Zeig-Owens”), “identified a modest effect of WTC exposure for all cancers combined by comparing the ratios in the exposed group [of Fire Department of New York City firefighters] to those in the non-exposed group.”
Following review of the STAC recommendation, the Administrator agreed with the STAC that individual exposure assessment information arising from the terrorist attacks is extremely limited and that its absence impairs definitive scientific analysis of the relationship between exposures arising from the attacks and the occurrence of any specific type of cancer. The Administrator also found that multiple epidemiologic studies of cancer in exposed responders and survivors which definitively support an association between 9/11 exposures and specific types of cancer that would meet generally well-accepted criteria indicating that the association is a causal one are not currently available.
After considering various approaches to evaluate the available scientific evidence (see discussion in the June 13, 2012 notice of proposed rulemaking), the Administrator has adopted the methodology outlined in the proposed rule and set out in Section IV below. This methodology follows on criteria used by the STAC in its recommendation. Using the methodology, the Administrator adds the types of cancer, identified in Section V below, to the List of WTC-Related Health Conditions.
In order for an individual enrolled as a WTC responder or survivor to obtain coverage for treatment of any health condition on the List of WTC-Related Health Conditions, including any type of cancer added to the List, a two-step process must be satisfied. First, a physician at a Clinical Center of Excellence (CCE) or in the nationwide provider network must make a determination that the particular type of cancer for which the responder or survivor seeks treatment coverage is both on the List of WTC-Related Health Conditions and that exposure to airborne toxins, other hazards, or adverse conditions resulting from the September 11, 2001, terrorist attacks is substantially likely to be a significant factor in aggravating, contributing to, or causing the type of cancer for which the responder or survivor seeks treatment coverage.
Title II of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347) reactivated the September 11, 2001 Victim Compensation Fund (VCF). Administered by the U.S. Department of
For the reasons discussed above and detailed in the notice of proposed rulemaking published in the
If only a single published epidemiologic study is available for review, the consistency of findings cannot be evaluated and strength of association will necessarily place greater emphasis on statistical significance than on the magnitude of the effect.
The following schematic illustrates the methodology proposed in the notice of proposed rulemaking and established in this final rule.
Using the evidentiary standards established above for inclusion of a cancer on the List of WTC-Related Health Conditions in 42 CFR 88.1, and in accordance with the review of evidence discussed in the notice of proposed rulemaking published in the
The final rule amends the definition of “List of WTC-Related Health Conditions” in 42 CFR 88.1, to include the types of cancer referenced above in Section V, which are the cancers proposed in the June 13, 2012, notice of proposed rulemaking (77 FR 35574). Table 1 in the regulatory text describes types of cancers included in 42 CFR 88.1 and identifies each by ICD-10 code. Because the ICD-10 modification will not be used by the U.S. healthcare system until October 1, 2014, the corresponding ICD-9 codes for the included cancer types are also provided in Table 1 in the regulatory text.
The effect of this amendment is that, for the types of cancers added, an enrolled WTC responder, certified-eligible survivor, or screening-eligible survivor may seek certification of a physician's determination that the September 11, 2001, terrorist attacks were substantially likely to be a significant factor in aggravating, contributing to, or causing the individual's cancer. As discussed above, if the condition is certified by the Administrator, the individual may seek treatment and monitoring of this condition under the WTC Health Program.
As described in the Public Participation section, above, the Administrator received 27 substantive submissions from the public on the methodology and the types of cancers proposed in the June 13, 2012
The Administrator agrees with the commenter that Methods 1 and 2, which rely on epidemiologic evidence (Method 1) and established medical relationships between a WTC-related health condition and the development of a type of cancer (Method 2), provide traditional methods for associating exposure and health effects as a means of adding conditions to the List of WTC-Related Health Conditions. However, the Administrator also recognizes that there is a continuum of methods that can be used to establish relationships between exposure and disease: some methods are more definitive and provide a higher level of certainty when establishing an association between exposure and disease outcomes. Adding cancers to the List by Methods 1 and 2 fall in that portion of the continuum of methods that provide greater certainty.
However, Methods 1 and 2 are substantially limited in their ability to provide timely guidance on which types of cancer should be added to the List of WTC-Related Health Conditions to allow the WTC Health Program to provide services to the responders and survivors currently suffering from cancers following exposure to 9/11 agents. Due to the long latency period between exposure and cancer diagnosis for most types of cancer, many epidemiological studies of cancer associated with particular exposures are produced years after a given exposure event. Waiting for definitive, scientifically-unassailable epidemiologic results before adding types of cancer to the List would prevent treatment of currently-enrolled WTC responders and survivors.
In addition, other factors make it difficult to establish definitive associations using traditional epidemiologic methods within
Because of the limitations of using epidemiologic studies to establish relationships between exposure and health effects, and the WTC Health Program's responsibility to provide services to affected individuals during their lifetime, the Administrator finds that this unique exposure situation merits the use of methods, in addition to Methods 1 and 2, that provide valuable information about the relationship between exposure and health effects. The Administrator acknowledges that Methods 3 and 4 provide less certainty about the relationship between exposure and cancer than do Methods 1 and 2.
Method 3 relies on identifying those agents categorized by the NTP as
Method 4 relies on findings from other sources of information relevant to 9/11 exposures and the potential occurrence of cancer, including the expert judgment and personal experiences of STAC members and comments from the public. The statute allows the Administrator to request a recommendation from the STAC. In this case, the Administrator requested a recommendation from the STAC as well as descriptions of the scientific and/or technical evidence members relied on, the quality of data supporting the evidence, and the methods used. The Administrator found the STAC recommendations and their bases to be reasonable.
Two comments correctly pointed out that the Zeig-Owens study, which was cited as evidence by the STAC, was viewed by the Administrator as not meeting the statistical significance threshold for Method 1. However, the Administrator made the determination to include certain cancers (e.g. thyroid and melanoma) using Method 4 based on a reasonable recommendation from the STAC. The interpretation of statistical significance can vary between knowledgeable observers. The STAC interpreted the Zeig-Owens results as a sound basis for recommending the addition of some types of cancer to the List when the reported statistical significance of findings in the study was near the traditional 95 percent confidence level. The Administrator has determined that the STAC's interpretation is reasonable.
The evidence cited by the STAC for including thyroid cancer and melanoma in their recommendation was that the Standardized Incidence Ratios (SIR) were substantially greater than 1.0 and approached the 95 percent confidence level traditionally used for statistical significance. The STAC also considered other types of cancer that had an elevated SIR in the Zeig-Owens study, such as prostate cancer, and did not recommend them for addition after considering additional information on potential surveillance bias. Thus, the STAC made reasonable arguments for the addition or exclusion of certain types of cancer. The STAC did not limit the basis of its recommendations to a level of statistical significance that would be recognized by all knowledgeable observers of epidemiologic studies.
Finally, the Administrator notes that listing a cancer as a WTC-related health condition does not necessarily mean that a cancer in an individual WTC responder or survivor will be determined to be WTC-related. Each WTC responder and survivor enrolled in the Program will go through a physician's determination and Program certification process to assess whether their individual cancer meets the
When determining whether an individual's cancer has been contributed to, aggravated by, or caused by their exposures at the 9/11 sites, an individual medical history and exposure assessment is used as part of the physician determination and Program certification process. Guidelines for physician determinations regarding WTC-related health conditions are jointly developed by the CCEs and the WTC Health Program for conditions on the List. The CCEs and WTC Health Program will develop additional assessment information for use by physicians in making determinations regarding whether an individual's 9/11 exposure may have contributed to, aggravated, or caused their cancer.
The methodology established in this final rule for adding types of cancer to the List includes identifying those agents categorized by IARC as being known, probable, or possible human carcinogens and having
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.
This rule has been determined to be a “significant regulatory action,” under sec. 3(f) of E.O. 12866. Accordingly, this rule has been reviewed by the Office of Management and Budget. The addition of specific types of cancer to the List of WTC-Related Health Conditions by this rule is estimated to cost the WTC Health Program between $2,124,624
The WTC Health Program has, to date, enrolled approximately 55,000 New York City responders and approximately 5,000 survivors, or approximately 60,000 individuals in total. Of that total population, approximately 59,000 individuals were participants in previous WTC medical programs and were `grandfathered' into the WTC Health Program established by Title XXXIII. These grandfathered members were enrolled without having to
As it is not possible to identify an upper bound estimate, HHS has modeled another possible point on the continuum. For the purpose of calculating the impact of an increased rate of cancer on the WTC Health Program, this analysis assumes that the entire statutory cap for new WTC responders (25,000) and WTC survivors (25,000) will be filled. Accordingly, this estimate is based on a population of 80,000 responders (55,000 currently identified + 25,000 new) and 30,000 survivors (5,000 currently identified + 25,000 new). The upper cost estimate also assumes an overall increase in population cancer rates of 21 percent due to 9/11 exposure,